AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) has achieved statistically significant and clinically meaningful improvement in treating hyperkalaemia in patients with end-stage renal disease (ESRD) on haemodialysis in phase 111b Dialize trial.
The Dialize trial has evaluated the efficacy and safety of Lokelma to treat hyperkalaemia, which is a serious condition indicated by elevated potassium levels in the blood.
According to the company, the 41.2% of patients with hyperkalaemia on stable haemodialysis receiving Lokelma maintained pre-dialysis normal potassium levels on at least three out of four dialysis treatments after the long interdialytic interval and did not require urgent rescue therapy in the trial, compared to 1.0% of patients receiving placebo.
Lokelma is a highly-selective and oral potassium-removing agent already approved for the treatment of adults with hyperkalaemia. It is already available in the US and EU.
Lokelma is an insoluble and non-absorbed sodium zirconium silicate formulated as a powder for oral suspension.
Dialize trial primary investigator Dr Steven Fishbane said: “An estimated two million people worldwide have end-stage renal disease, placing them at a higher risk for hyperkalaemia.”
Data from the Dialize trial will help in label updates in the US and EU, as the dosing regimen used in the trial is not currently approved.
Dialize is claimed to be the first ever randomised and placebo-controlled trial designed to assess a potassium binder in patients on stable haemodialysis.
The multicentre and double-blind study evaluated the efficacy of Lokelma versus placebo in 196 patients on haemodialysis with hyperkalaemia.
Patients have been randomised to secure Lokelma or placebo once daily on non-dialysis days for a treatment period of eight weeks, including a four week dose adjustment phase and four week evaluation phase on stable dose.
AstraZeneca bioPharmaceuticals R&D and late-stage development, cardiovascular, renal and metabolism head and senior vice president Elisabeth Björk said: “These positive results show that Lokelma can normalize potassium levels in between dialysis sessions for patients with hyperkalaemia who have end-stage renal disease.
“There is a high unmet treatment need that affects a large patient population and we believe Lokelma can play a critical role.”